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Understanding oversight in COVID-19 vaccine trials amid setbacks

Medical experts say the boards appointed to oversee vaccine studies are independent of the FDA and ensure safety of research.

TAMPA, Fla. — Signing up for a COVID-19 vaccine clinical trial can seem like a gamble between risk and reward, especially amid news of the halted AstraZeneca research, but medical experts say the boards appointed to oversee vaccine studies did exactly what they were supposed to do.

“I don't think anything went wrong with the data safety monitoring board or the vaccine clinical trial,” said Dr. Kevin Sneed of the University of South Florida’s Taneja College of Pharmacy. “As a matter of fact, just the simple fact they stepped in and halted the trial to do a thorough investigation really does show that the process is working exactly how it was designed to work."

For every vaccine trial, an independent group of clinical doctors, statisticians and patient advocates come together on a "Data Safety Monitoring Board (DSMB)." This board oversees the trial's data and safety.

"These are individuals that have no direct contact with the researcher or the company,” Dr. Sneed said.

They intervene when something goes wrong, and the FDA cannot move forward with a vaccine until the DSMB board says it's safe. So, while headlines about the AstraZeneca trial being paused are concerning, scientists say the board did its job.

"I think this is a good, perhaps a wake-up call or a lesson for everyone to recognize the fact that there are ups and downs in research, there are ups and downs in clinical development and we have to be prepared for those,” said World Health Organization Chief Scientist, Soumya Swaminathan.

But what we shouldn't have to worry about is politics impeding the process. This became a concern for some when the Trump administration asked states to be ready to distribute vaccines by November 1, two days before Election Day.

"The only politics that can really enter into anything going on with the coronavirus vaccine trials, would be if we were to bypass and not complete the Phase Three clinical trial process, and immediately seek an emergency use authorization without having all of the data analyzed appropriately,” Dr. Sneed said.

Doctors say even when Phase Three clinical trials are complete, there is no guarantee that a participant won't have an adverse reaction. However, completing the study and analyzing the data minimizes that risk.

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